Insulin Pump Therapy in Older Adults

Insulin Pump Therapy in Older Adults Joshua Akers, PharmD Candidate, 2007 College of Pharmacy Washington State University Spokane, WA Phone: 509-432-3332 Email: akersjoshua@hotmail.com and Stephen M. Setter, PharmD, CDE, CGP, DVM** Associate Professor of Pharmacotherapy College of Pharmacy Washington State University Elder Services Spokane, WA 99217 Phone: 509-489-9283 FAX: 509-458-7450 Email: ssetter@smhca.org **Corresponding Author

Introduction It is currently estimated that roughly 18.2 million people in the U.S. have diabetes (1), a number expected to grow as our population ages. Diabetes is a progressive disease with many patients eventually requiring insulin therapy. Searching for improved ways to administer insulin is worthwhile as many people with diabetes balk at the idea of injecting insulin. While insulin injections are the most traditional method of administering insulin, there are other options. Newer advances such as inhaled insulin and jet injectors are available for use, though they may not be appropriate for all individuals. The other alternative is an older but constantly advancing technology that attempts to mimic pancreatic insulin release, the insulin pump. Insulin Pumps Purchasing an insulin pump is a major life decision for any individual with diabetes. Insulin pumps assist patients in gaining improved blood glucose control while providing a freer lifestyle. An insulin pump is a small device, about the size of a beeper or cell phone, which is generally worn on a person s waistline. The pump is connected to the body through a catheter and line of tubing, referred to as the infusion set. All but one of the available pumps, the Insulet Omnipod, requires an infusion set. The pump works by delivering a continuous basal insulin dose and by administering premeal bolus doses. The basal dose is given throughout a 24 hour period to cover glucose levels overnight and between meals. Depending on the pump, this basal dose can be adjusted in different ways and can have preset programs that allow the basal rate to be easily altered. The bolus dose is given prior to meals to cover post-meal blood glucose excursions. One of the

advantages to an insulin pump is that a bolus dose can be given with the push of a couple buttons, making it much more convenient to administer insulin. Rapid-acting insulin analogs such as Humalog, Novolog, or Apidra or short-acting Regular human insulin can be used in pumps. The individual must refill their insulin pump themselves with whatever insulin that they and their physician have decided as most appropriate. Fortunately, most insulin pumps are equipped with a low-insulin alarm to help people remember to refill their insulin cartridge. Choosing an insulin pump There are certain criteria that are important in choosing an insulin pump. According to the American Diabetes Association, the most important criteria are(2): Cosmetic Attractiveness Clinically desirable features Ease of Use Safety Features Durability Availability of service and training Water Resistance

These are all important things to consider when thinking about starting insulin pump therapy. However, older persons may consider certain things more important when determining the best pump for them. Specific questions to consider include: Is it going to be too heavy for me to wear? How will I remember when to check my glucose and when to inject a bolus dose? I don t know how to count carbs, can the pump help me do this? How will I know when to change the batteries? I have poor eyesight, is the screen large enough to read? Are there any features to help me see? What if I forget that I already gave myself a dose? Will the pump help prevent me from injecting too much? I have trouble with arthritis and using smaller devices, is there anything that can help me enter bolus dosing and blood glucose values? How will I know if the pump is operating correctly? Some of these new pumps I hear about seem so technical. Is there something simple to use? I m on Medicare and need to watch how much I spend. How much will these pumps cost me? Are the supplies easy to purchase? While there is no one pump that can provide an answer for each of these questions, the pumps available all have features that can assist older individuals in administering insulin. Features

such as audio bolusing, remote controls, beaming technology, and insulin-on-board are a few examples of things that can help. Thus it becomes important for each individual to decide on what is most important to them when choosing an insulin pump. Older patients along with their health care provider and/or certified diabetes educator can then assist with making the best and most informed decision possible. The accompanying table is a summary of the insulin pump products that are currently available for purchase in the U.S. While this table is not an all-inclusive guide to every aspect of every pump, it does provide basic information to assist in identifying the various features of the available pumps. It also provides answers to some questions regarding insulin pumps, highlights unique features, and provides considerations for older populations, as well as listing the cost. This table is a reference only and should not be the only tool used in determining the most appropriate pump, nor does it cover differences between infusion sets. To find out more information about any pump, please contact the manufacturer directly.

Explanation of select terms used in the chart *Insulin on Board (IOB) this is a feature that monitors how long insulin is active in the body based on user defined settings. This allows people to tailor their dosing based on their own insulin sensitivity. *Connection The standard infusion set utilizes a luer-lock connection. If a different connection is indicated, then a special infusion set must be used for that pump. *Basal Programs these are basal programs that alter the rate at which basal insulin is delivered. For example, a person could have one basal program for sleeping, and another program for when they exercise, and another for working. These preset programs allow for easier and faster switching of a person s basal rate, thus individualizing their insulin therapy. *Bolus Increments controls the units by which a bolus dose is measured. This is generally entered manually (directly on the pump), though some pumps allow the bolus dose to be entered by audio (speak the desired dose into the pump) or by remote (small remote allowing more discretion in using the pump). *Bolus Duration the rate at which a bolus is given can be very important if someone does not tolerate a dose being injected too fast. It also can be important to control the insulin delivery for people with gastroparesis or if a high fat meal is consumed. Different pumps provide many

different options and it is important to choose a pump that is comfortable and best fits your lifestyle. *Carbohydrate dosing program some pumps will automatically calculate a bolus dose based on the amount of carbohydrates (carbs) being consumed. Most require a patient to count the carbs they re eating, though some newer pumps allow patients to simply enter the food. The pump can then calculate the dose, thus removing the need to count carb intake. *Blood glucose testing from monitor this is the incorporation of a blood glucose testing system with the pump itself. Currently only 2 systems have this feature, the Insulet Omnipod and the Medtronic Paradigm system if used with the REAL-time system. *Cost Consideration all prices for pumps are for the cash price only. Different insurance companies may have different pricing, so the pricing may be drastically different depending on a person s specific insurance plan.

References 1. Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2003. Rev ed. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2004. 2. American Diabetes Association. Position Statement: Continuous Subcutaneous Insulin Infusion. Diabetes Care. 2002; 25:S116

Animas IR 1000 Animas IR 1200 Animas IR 1250 Insulin Pump System Size (inches) 3.5x 2.2 x 0.7 2.9 x 2.0 x 0.76 2.9 x 2.0 x 0.76 Weight (oz) 3.8 3.1 3.1 Insulin Holding Capacity (ml) 3 2 2 Connection Luer-Lok Luer-Lok Luer-Lok Screen Size, Backlight N/A, Yes 1.5 in 2, No 1.5 in 2, No (contrast control) Color Availability Interchangeable cover allows wide assortment of colors and styles Wide assortment of colors and styles Silver, Blue, Black Basal Range 0.05 9.9U/hr 0.025 25U/hr 0.025 25U/hr Basal Programs Up to 4 personalized programs Up to 4 personalized programs Up to 4 personalized programs Basal Delivery Every 3 minutes Every 3 minutes Every 3 minutes Bolus Increments Bolus Duration Battery Type/Life 0.1U Manual 0.5U & 1.0U Audio Immediate (8 sec), extended (1/2 4 hours), or combo Four 357 silver oxide 6-8 weeks 0.05U Manual 0.1U, 0.5U & 1.0U Audio Immediate (8 sec), extended (1/2 4 hours), or combo One AA Lithium, 6-8 weeks One AA Alkaline, shorter 0.05U Manual 0.1U, 0.5U & 1.0U Audio Immediate (8 sec), extended (1/2 4 hours), or combo One AA Lithium, 6-8 weeks One AA Alkaline, shorter Low Battery Alert? Insulin on board Feature? Built-in Carbohydrate dosing program? Blood glucose testing by monitor? Memory Downloadable Records? No Yes Yes No Yes Yes No No No 255 boluses & 255 total daily doses 600 boluses,120 total daily doses & 270 basals 600 boluses,120 total daily doses & 270 basals Water Resistant? Low-Insulin Alarm? Line-Occlusion Alarm? Over-Delivery Alarm? Yes Yes, user may set level for the alarm Yes, user may set level for the alarm No, only redundant safety features No, only redundant safety features No, only redundant safety features

Animas IR 1000 Animas IR 1200 Animas IR 1250 Insulin Pump System Unique Features Geriatric Feasibility Cost Considerations Various covers, designs, etc. available to make the pump unique to the individual Insulin gauge allows for partial fills of insulin cartridge Small screen size makes visibility difficult Any Luer Lok set available makes infusion set supply purchases easier Multiple Alarm systems increase safety and alert user of various IP issues Changing batteries more difficult with smaller, less common battery. Larger insulin resevoir resulting in cartridge change every 3 days decreases opportunities to miss doses Patient still must remember to test their glucose daily, not automatic from pump Various redundant safety features make it a durable and reliable pump Audio bolus allows for less error in pump controls $5,475 Any Luer Lok infusion set allows for shopping for best deal Insurance more likely to pay Still must have glucose meter and regularly replace strips and lancets Various covers, designs, etc. available to make the pump unique to the individual BG & Mealtime bolus alarms Larger screen size better for visibility, though font still small Carbohydrate bolus calculator helpful if user understands how to count carbs Any Luer Lok set available makes infusion set supply purchases easier Multiple Alarm systems increase safety and alert user of various IP issues Various redundant safety features make it a durable and reliable pump Patient still must remember to test their glucose daily, though alarms present to assist in remembering Self-priming makes set-up easier for patient Audio bolus allows for less error in pump controls $5,975 Any Luer Lok infusion set allows for shopping for best deal Still must have glucose meter and regularly replace strips and lancets Screen contrast control BG & Mealtime bolus alarms Ability to store carb info and create meals up to 9 items Can upload music files to use as alarms Larger screen size and contrast control better for visibility, Carbohydrate Food memory better as it can be tailored to patients meal trends Any Luer Lok set available makes infusion set supply purchases easier Multiple Alarm systems increase safety and alert user of various IP issues Various redundant safety features make it a durable and reliable pump Patient still must remember to test their glucose daily, though alarms present to assist in remembering Self-priming makes set-up easier for patient Audio bolus allows for less error in pump controls $5,975 Any Luer Lok infusion set allows for shopping for best deal Still must have glucose meter and regularly replace strips and lancets

Disetronic Spirit Insulet - Omnipod Deltec - Cozmo Insulin Pump System Size (inches) 3.2 x 2.2 x 0.8 inches Pod: 1.6 x 2.4 x 0.7 PDM: 2.6 x 4.3 x 1.0 3.2 x 1.8 x 0.9 Weight (oz) 2.8 Pod: 1.2 PDM: 4.0 3.3 Insulin Holding Capacity (ml) 3.15 2 3 Connection Luer-Lok Built-in to Pod (no tubing) Luer-Lok Screen Size/Backlight N/A, yes 1.75 in 2, yes 1.35 in 2, Yes Pod: white Color Availability 30 different colors and styles PDM: silver Blue, Black, Purple Basal Range 0.1 25 U/hr 0.05 30U/hr 0.05 35U/hr Basal Programs 5 different personalized programs Up to 7 different personalized programs 4 different personalized programs Basal Delivery Every 3 minutes N/A Every 3 minutes Bolus Increments 0.1U, 0.2U, 0.5U, 1.0U & 2.0U 0.05U, 0.1U, 0.5U & 1.0U 0.05U Bolus Duration Immediate (5 sec), or Extended (15min. 24 hrs.), or combo N/A 1 5 minutes Battery Type/Life One alkaline AA, ~3 weeks Two alkaline AAA, ~4 weeks One alkaline AAA, ~30 days Low Battery Alert? Insulin on board Feature? Built-in Carbohydrate dosing program Blood glucose testing by monitor? Memory Downloadable Records? Water Resistant? Low-Insulin Alarm? Line-Occlusion Alarm? Over-Delivery Alarm? No Yes Yes Yes, in PDA Yes Yes No Yes, Freestyle Monitor No Last 30 alerts, errors, boluses, daily insulin totals, and temporary basal rate changes 90 day memory (up to 5400 records) 4000 Events Yes No Yes Yes N/A Yes Yes No Yes

Disetronic Spirit Insulet - Omnipod Deltec - Cozmo Insulin Pump System Unique Features Reversible screen allows pump to be worn multiple ways System comes with either Zire 31 or Palm Treo 650 PDA and Accu-Chek BG monitor Equipped with wireless capabilities Carb database and controller included in Palm device 12 different language settings possible Automatic priming feature Unique technology gets rid of tubing associated with pump Integrated Freestyle system makes BG testing much easier Small and very lightweight. Lightest and smallest available on market Automatic insertion and priming BG results automatically converted into bolus calculations Carbohydrate library to assist in bolus dosing Includes CoZmonitor that uses Freestyle technology for BG testing that attaches to the pump and can send BG results directly to pump Can work on beep or vibrate mode Glucose testing alarms to ensure regular testing Geriatric Feasibility PDA technology could be confusing and excessive Screen size appears small, but backlight could help with visibility Carbohydrate database useful if user understands how to utilize it Any Luer Lok set available makes infusion set supply purchases easier Patient still must remember to test their glucose daily, not automatic from pump (though alarm may be present to help) Larger insulin resevoir resulting in cartridge change every 3 days decreases opportunities to miss doses Multiple on-screen icons, vibrations, beeps, and sounds to assist in operation PDM technology simpler than a PDA, but could still be confusing Large screen and font makes visibility much easier than any other pump Carbohydrate database useful if user understands how to utilize it No need to learn to use multiple systems Automatic BG testing and bolus calculation makes use easier System dependent on PDM which could be problematic if patient loses the PDM Safety concerns over lost PDM, removal of Pod, or malfunctioning of Pod not addressed No tubing to get caught, lower chance of pulling out insulin pump Patient does not have to refill insulin cartridge Multiple Alarm systems increase safety and alert user of various IP issues Larger insulin resevoir (712) resulting in cartridge change every 3 days decreases opportunities to miss doses Patient still must remember to test their glucose daily, though alarms present to assist in remembering Carb bolus doing available, but patient must be able to count carbs Any Luer Lok set available makes infusion set supply purchases easier Requires PC for certain history features which could be problematic IOB could help prevent overbolusing Cost Considerations Any Luer Lok infusion set allows for shopping for best deal Purchasing pump, PDA, and monitor could make for a very expensive system $800 for the PDM $325 for 10 pack of pods (~30 day supply) No infusion set purchases need to be made $5,595 (includes BG meter) Any Luer Lok infusion set allows for shopping for best deal Still must regularly replace strips and lancets for glucose meter

Medtronic Paradigm 522/722 Nipro - Amigo DANA Diabecare II Insulin Pump System 522: 3.0 x 2.0 x 0.8 Size (inches) 722: 3.6 x 2.0 x 0.8 3.2 x 2.1 x 0.9 3.0 x 1.8 x 0.74 Weight (oz) 3.5 3.1 1.8 Insulin Holding 522: 1.76 Capacity (ml) 722: 3 3 3 Connection Specific proprietary sets Luer-Lok Proprietary DANA set Screen Size/Backlight 1.2 in 2, yes N/A, Yes N/A, Yes Midnight, Flamingo, Pacific, Color Availability Clear, Blue, Smoke, Purple Grape, Snow, Solar Black, Gray, Blue, Ivory Basal Range 0.05U 35.0U/hr 0.05 10U/hr 0.1 16U/hr Basal Programs 3 different personalized programs Up to 4 different personalized programs 1 personalized programs Basal Delivery 0.1U Pulses Every 3 or 15 minutes Every 4 minutes Bolus Increments Bolus Duration Battery Type/Life 0.1U, 0.5U & 1.0U Manual 0.5U & 1.0U Audio or Remote Immediate pulse, extended pulse, or combo One alkaline AAA, 3-4 weeks 0.1U 0.1U Immediate (5 or 15 sec), Extended (15min 6 hours), or combo One CR2 Camera battery, 4-6 weeks 8 sec Proprietary DANA battery, 2 3 months Low Battery Alert? Yes N/A Yes Insulin on board Feature? Built-in Carbohydrate dosing program Blood glucose testing by monitor? Yes Yes No Yes (If purchased with REALtime upgrade) Memory 90 Days 90 Days Downloadable Records? Water Resistant? Low-Insulin Alarm? Line-Occlusion Alarm? Over-Delivery Alarm? No No 50 boluses, Primes, total daily doses & last 12 alarms Yes Yes No

Medtronic Paradigm 522/722 Nipro - Amigo DANA Diabecare II Insulin Pump System Unique Features Geriatric Feasibility Optional remote control Can work on beep or vibrate mode REAL-time BG monitoring takes a BG reading every 5 minutes. This result is sent to the pump for constant BG monitoring including BG trends throughout the day Can view previous 31 days of pump activity on pump screen Multiple visual & audio Alarm systems increase safety and alert user of various IP issues Larger insulin resevoir (722) resulting in cartridge change every 3 days decreases opportunities to miss doses Constant testing removes need for multiple devices No indicator on remote as to how much bolus dose entered Constant monitoring allows for much greater control on basal and bolus dosing REAL-time alarms go off on preset glucose levels. Could greatly reduce instances of hypo- or hyperglycemia Carb bolus doing available, but patient must be able to count carbs Sleek casing design to help avoid snags on clothing Glucose testing alarms to ensure regular testing Multiple Alarm systems increase safety and alert user of various IP issues Larger insulin resevoir (712) resulting in cartridge change every 3 days decreases opportunities to miss doses Patient still must remember to test their glucose daily, though alarms present to assist in remembering Carb bolus doing available, but patient must be able to count carbs Any Luer Lok set available makes infusion set supply purchases easier Changing batteries more difficult with smaller, less common battery. Preset meal boluses can be utilized for breakfast, lunch, and/or dinner Glucose testing alarms to ensure regular testing Optional wireless remote Multiple Alarm systems increase safety and alert user of various IP issues Larger insulin resevoir (712) resulting in cartridge change every 3 days decreases opportunities to miss doses Patient still must remember to test their glucose daily, though alarms present to assist in remembering Specific infusion set, battery purchases and special ordering could make supply acquisition difficult and confusing Changing batteries more difficult with smaller, less common battery. Poor resolution on screen could make visibility difficult Cost Considerations $6,195 for pump $999 for Real-time Only specific infusion sets usable limits options Will still need to buy supplies for REAL-time testing, increasing expenses REAL-time system costs extra and may not be covered by insurance ~$5,495 Any Luer Lok infusion set allows for shopping for best deal Still must have glucose meter and regularly replace strips and lancets ~$3,700 Can only use DANA infusion sets, limiting purchasing options Still must have glucose meter and regularly replace strips and lancets